The present invention relates generally to Y-port adaptors of the type suitable for use with medical catheters, such as percutaneous endoscopic gastrostomy (PEG) tubes and percutaneous endoscopic jejunostomy (PEJ) tubes, and relates more particularly to a novel Y-port adaptor of the aforementioned type and to a medical catheter assembly including the same.
Certain patients are unable to take food and/or medications transorally due to an inability to swallow. Such an inability to swallow may be due to a variety of reasons, such as esophageal cancer, neurological impairment and the like. Although the intravenous administration of food and/or medications to such patients may be a viable short-term approach, it is not well-suited for the long-term. Accordingly, the most common approach to the long-term feeding of such patients involves gastrostomy, i.e., the creation of a feeding tract or stoma between the stomach and the upper abdominal wall. Feeding is then typically performed by administering food through a catheter or feeding tube that has been inserted into the feeding tract, with the distal end of the feeding tube extending into the stomach and being retained therein by an internal anchor or bolster and the proximal end of the feeding tube extending through the abdominal wall.
(For certain patients, it is desirable for food to be administered directly to the patient's jejunum, without first passing through the patient's stomach. In such cases, a jejunostomy is typically performed, a jejunostomy being similar to a gastrostomy, except that a jejunostomy results in the distal end of the feeding tube being implanted in the patient's jejunum, instead of in the patient's stomach.)
Although gastrostomies were first performed surgically, most gastrostomies are now performed using percutaneous endoscopy and result in the implantation of a catheter/bolster assembly (also commonly referred to as a percutaneous endoscopic gastrostomy (PEG) device) in the patient. Two of the more common techniques for implanting a PEG device in a patient are “the push method” (also known as “the Sacks-Vine method”) and “the pull method” (also known as “the Gauderer-Ponsky method”). Summaries of the push method and the pull method are provided below; additional information regarding these two methods may be found in the following patents, all of which are incorporated herein by reference: U.S. Pat. No. 5,391,159, inventors Hirsch et al., which issued Feb. 21, 1995; U.S. Pat. No. 5,167,627, inventors Clegg et al., which issued Dec. 1, 1992; U.S. Pat. No. 5,112,310, inventor Grobe, which issued May 12, 1992; U.S. Pat. No. 4,900,306, inventors Quinn et al., which issued Feb. 13, 1990; and U.S. Pat. No. 4,861,334, inventor Nawaz, which issued Aug. 29, 1989.
According to the push method, the distal end of an endoscope is inserted into a patient's mouth and is passed through the esophagus into the stomach. After distension of the stomach by inflation, an entry site on the abdomen is identified, and an incision is made by passing a needle with an outer cannula (e.g., a Seldinger needle) through the abdominal wall and into the stomach. The needle is then removed while keeping the cannula in place. Next, a snare is inserted into the stomach via the endoscope and is looped over the distal end of the cannula. A first end of a flexible guidewire is then passed through the cannula and into the stomach where it is grasped by the snare, the second end of the guidewire remaining external to the patient. The endoscope and the snare are then withdrawn from the mouth of the patient to deliver the first end of the guidewire.
A push-type catheter implanting assembly is then inserted over the first end of the guidewire and is pushed over the guidewire towards its second end. The push-type catheter implanting assembly typically comprises a gastrostomy feeding tube, the gastrostomy feeding tube having a dome-shaped internal bolster disposed at its trailing end and having a tubular dilator serially connected to its leading end. The gastrostomy feeding tube and the internal bolster are typically made of a soft, biocompatible material, like silicone rubber, and may form a unitary structure. The dilator, which tapers in outer diameter from its trailing end to its leading end, is typically made of polyethylene or a like material which is stiffer than silicone but which still possesses some flexibility. Advancement of the push-type catheter implanting assembly over the guidewire continues until the front end of the dilator reaches the cannula and pushes the cannula out through the abdominal wall of the patient. The front end of the dilator is then pulled through the abdominal wall until the front or proximal end of the gastrostomy feeding tube emerges from the abdomen and, soon thereafter, the internal bolster at the rear or distal end of the gastrostomy feeding tube engages the gastric wall.
According to the pull method, the distal end of an endoscope is inserted into a patient's mouth and is passed through the esophagus into the stomach. After distension of the stomach by inflation, an entry site on the abdomen is identified, and an incision is made by passing a needle with an outer cannula (e.g., a Seldinger needle) through the abdominal wall and into the stomach. The needle is then removed while keeping the cannula in place. Next, a snare is inserted into the stomach via the endoscope and is looped over the distal end of the cannula. A first end of a suture is then passed through the cannula and into the stomach where it is grasped by the snare, the second end of the suture remaining external to the patient. The endoscope and the snare are then withdrawn from the mouth of the patient to deliver the first end of the suture. The first end of the suture is then coupled to the leading end of a pull-type catheter implanting assembly, the pull-type catheter implanting assembly comprising a gastrostomy feeding tube having an internal bolster at its trailing end and a plastic fitting at its leading end. The plastic fitting has a barbed rear portion mounted within the leading end of the feeding tube and a conical front portion that serves as a dilator, said conical front portion tapering in diameter from the leading end of the feeding tube to a front tip. A wire loop is fixed to the front tip of the plastic fitting, the first end of the suture being tied to the wire loop. Using the second end of the suture, the pull-type catheter implanting assembly is then pulled retrograde through the patient until the front or proximal end of the gastrostomy feeding tube emerges from the abdomen of the patient and, soon thereafter, the internal bolster at the rear or distal end of the gastrostomy feeding tube engages the gastric wall of the patient.
Regardless of whether the push method or the pull method is employed, the next steps of the procedure typically involve cutting and removing a proximal portion of the implanted gastrostomy feeding tube to reduce the externally-extending portion of the tube to a desired length (typically about 4-6 inches), securing an external bolster to the remaining exposed length of the implanted tube to prevent the withdrawal of the proximal end of the tube into the patient's stomach, and attaching a “Y-port” adaptor to the proximal end of the implanted feeding tube.
The Y-port adaptor is typically a unitary, tubular member made of silicone or the like and having an unbranched distal end and a branched proximal end. The unbranched distal end of the Y-port adaptor is typically shaped to include a barb, said barb being inserted into the proximal end of the implanted feeding tube and being appropriately sized to secure the Y-port adaptor to the feeding tube. The branched proximal end of the Y-port adaptor is typically shaped to include a pair of lumens, a larger diameter lumen and a smaller diameter lumen. The larger diameter lumen is adapted to receive the dispensing tip of a syringe or feeding set adapter of the type through which food is typically dispensed. The smaller diameter lumen is adapted to receive the dispensing tip of a syringe or feeding set adapter of the type through which medication is typically dispensed.
The Y-port adaptor typically also includes a pair of tethered plugs, the plugs being used to ‘cap’ the lumens when the lumens are not in use (the Y-port adaptor typically remaining secured at all times to the proximal end of the feeding tube). In this manner, the plugs prevent undesired materials from entering the patient through the Y-port adaptor. At the same time, the plugs are also intended to prevent the escape of the patient's stomach contents through the Y-port adaptor. As can readily be appreciated, the escape of the patient's stomach contents through the Y-port adaptor is undesirable as it often results in the soiling of the patient and/or his environment, thereby requiring cleanup. In addition, the escape of the patient's stomach contents may result in a loss of nutritional requirements to the patient. Furthermore, when the patient's stomach contents include contagions, the escape of the patient's stomach contents may result in the spread of disease to other individuals coming into contact with said stomach contents.
Unfortunately, the plugs used to cap the lumens of the Y-port adaptor have a tendency, over time and after repeated usage, to leak and to become easily ousted from their respective lumens. Moreover, for certain patients that suffer from conditions that result in increased stomach pressure (such as those suffering from Gastroparesis), it is not uncommon for the plugs to be expelled from their respective lumens simply by pressure exerted from within the stomach. As can readily be appreciated, the failure of the plugs to maintain a tight seal within their respective lumens leads to the undesirable escape of stomach contents through the Y-port adaptor.
Moreover, even if the plugs operate as desired to keep the lumens closed between feedings, one must still remove a plug from its respective lumen if one wishes to insert the dispensing tip of a syringe or feeding set adapter into the lumen so that food or medications may be administered to the patient. However, this temporary “opening” of the Y-port adaptor—subsequent to the removal of the plug and prior to the insertion of the dispensing tip into the lumen—presents an unfortunately ideal opportunity for the patient's stomach contents to be expelled from the patient. Moreover, because the removal of a plug is often performed by a healthcare provider standing directly in front of the Y-port adaptor, it is not uncommon for the healthcare provider, upon removing the plug from its lumen, to be sprayed with the patient's stomach contents, thereby subjecting the healthcare provider to any contagions present in the stomach contents.